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Unit Dose Solutions Compliance & Quality Assurance

UDS Compliance & Quality Assurance


We provide our clients with the highest quality services that will not only help you in the short-term, but also reap benefits long-term. Our commitment to quality can be seen with adhering to the highest packaging industry standards. UDS is licensed by State Boards, DEA and is registered with FDA. UDS conducts routine internal audits and quarterly quality reviews (includes deviations, CAPA, Change Control, Customer Issue Resolution, Recalls, etc.). We utilize these audits to determine adverse trends and to optimize our processes when needed/mandated.

UDS has an Independent Quality Assurance department that ensures we are compliant with FDA cGMP regulations (21 CFR Parts 210, 211, 820). UDS has and will host audits from FDA, DEA, or customers when the need arises (previous audit information is available upon request).

• Drug Supply Chain Security Act compliance

• State and federally registered facility governed by the FDA and DEA

• External laboratory validated cleaning procedures

• International Organization for Standardization (ISO) based in process QC inspections

• Professional cGMP consultation and training

• Corrective and Preventive Action Plan procedure (CAPA)

• Quality Control Unit (QCU) audited production and process controls

• Internal cGMP auditing program

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Unit-Dose & Multi-Dose Packaging & Supplies